Roche and Pharmasset Join Forces to Develop New Generation of Hepatitis C Therapies

NUTLEY, N.J. and ATLANTA -- Roche and Pharmasset announced a partnership to develop nucleoside polymerase inhibitors for the treatment of chronic hepatitis C virus (HCV) infections. Pharmasset will receive an upfront fee, research and development support and milestone payments that could total $168 million for PSI-6130, the lead nucleoside compound of the partnership. In addition, Pharmasset will receive royalties on product sales and retain certain co-promotion rights in the United States.

PSI-6130 may have the potential to offer greater efficacy and activity against the hepatitis C virus, especially in combination with Roche's Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP). For patients who do not respond to current therapy, the addition of nucleoside polymerase inhibitors to the treatment regimen may offer benefit.

"Pharmasset's expertise in nucleoside drug discovery and early stage clinical development, combined with Roche's proven track record in bringing new and improved hepatitis C therapies to market is a formula for success," stated Schaefer Price, Pharmasset's president and CEO. "The economics of this deal are significant. In addition, this partnership will support Pharmasset's activities toward establishing a commercial infrastructure for our HIV and HCV clinical candidates."

"Roche has already established itself in hepatitis C with Pegasys, the most prescribed hepatitis C medication in the U.S. This collaboration with Pharmasset demonstrates our ongoing commitment to advancing therapy for hepatitis C patients with unmet needs," said George Abercrombie, president and CEO, Hoffmann-La Roche Inc. "We hope that further research and development will show that PSI-6130 is an important new hepatitis C treatment option that complements Pegasys and Copegus."

Under the terms of the agreement, Roche will gain the worldwide rights, excluding Latin America and Korea, to Pharmasset's PSI-6130 and its prodrugs. Pharmasset will be responsible for preclinical work, investigational new drug (IND) filings, and phase I proof of concept studies, with Roche managing other preclinical studies and clinical development. Roche will also receive options to related nucleoside polymerase inhibitors, which, if exercised, could result in Pharmasset receiving in excess of $300 million in total milestones under the agreement. Pharmasset will continue to develop and retain worldwide rights to ongoing and future hepatitis C programs unrelated to the PSI-6130 series of nucleoside polymerase inhibitors. In addition, the Roche Venture Fund has made a $4 million investment in Pharmasset and has received warrants to purchase an additional $6 million in shares within the next two years at a premium price. About HCV Hepatitis C is a blood-borne infectious disease of the liver and the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the United States. An estimated 2.7 million Americans are chronically infected with hepatitis C.

Source: Roche, Pharmasset, Inc.